Combination Chemotherapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have prostate cancer that has not responded to hormone therapy.
Drug: doxorubicin hydrochloride
Procedure: pain therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Doxorubicin and Cyclophosphamide With Sequential Docetaxel in Patients With Hormone-Refractory Prostate Cancer|
|Study Start Date:||October 1999|
OBJECTIVES: I. Determine the PSA response, duration of PSA response, disease free survival, median survival, and overall survival in patients with chemotherapy naive hormone refractory adenocarcinoma of the prostate treated with doxorubicin and cyclophosphamide with sequential docetaxel. II. Assess for any improvement in pain over time in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive doxorubicin IV over 3-5 minutes and cyclophosphamide IV on days 1, 22, 43, and 64, and docetaxel IV over 1 hour on days 85, 106, and 127 in the absence of disease progression or unacceptable toxicity. Patients receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after completion of chemotherapy infusions and continuing until blood counts recover. G-CSF must be discontinued at least 24 hours prior to starting subsequent chemotherapy infusions. Pain and analgesic use are assessed before study, every 3 weeks during study, after completion of study, and then at 3 months after completion of study. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until death.
PROJECTED ACCRUAL: Approximately 42-105 patients will be accrued for this study over 18 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005960
|United States, California|
|Wilshire Oncology Medical Group, Inc.|
|Los Angeles, California, United States, 90057|
|United States, Florida|
|Geffen Cancer Center and Research Institute|
|Vero Beach, Florida, United States, 32960-6541|
|United States, New York|
|Arena Oncology Associates|
|Great Neck, New York, United States, 11021|
|New York Medical College|
|Valhalla, New York, United States, 10595|
|United States, North Carolina|
|N.W. Carolina Oncology & Hematology, P.A.|
|Hickory, North Carolina, United States, 28603|
|United States, Pennsylvania|
|Associates of Hematology/Oncology|
|Upland, Pennsylvania, United States, 19013|
|Study Chair:||Debra Litwak, PharmD||Amgen|